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    Summary
    EudraCT Number:2008-006257-40
    Sponsor's Protocol Code Number:ACI-24-0701
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2008-006257-40
    A.3Full title of the trial
    A Phase I/II Double-Blind, Randomised, Placebo-Controlled, Adaptive Design Study of the Safety, Tolerability, Immunogenicity and Efficacy of ACI-24 in Patients with Mild to Moderate Alzheimer's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the safety and effects of a new compound, ACI-24 with placebo in patients with mild to moderate Alzheimer's disease
    A.4.1Sponsor's protocol code numberACI-24-0701
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAC Immune SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPrivate Shareholder
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPrivate Shareholder
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAC Immune SA
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressEPFL Innovation Park, Building B
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1015
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41213459121
    B.5.5Fax number+41213459120
    B.5.6E-mailclinicaltrials@acimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameACI-24
    D.3.2Product code ACI-24
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePal1-15 acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number340 to 460
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall study objective is to assess the safety, immunogenicity and efficacy of repeated doses of ACI-24 at 4 different dose levels administered to patients with mild to moderate Alzheimer’s disease (AD) patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to explore:
    - the efficacy of ACI-24 in reducing Aβ level in the brain of patients with mild to moderate Alzheimer's disease
    − the effect of ACI-24 on whole brain and hippocampal volume (for Step 2 only)
    − the effect of ACI-24 on T cell activation
    − the effects of ACI-24 on putative biomarkers of the progression of Alzheimer's disease like total tau and phosphorylated tau protein (phosphotau) and Aβ levels (Aβ1-42 and Aβ1-40) in blood and CSF
    - the efficacy of ACI-24 on clinical/cognitive endpoints in patients with mild to moderate Alzheimer's disease
    - the induction of immune response in serum and/or CSF including, but not limited to, anti-Aβ1-42 IgM titer in blood
    - the induction of inflammatory cytokines in blood
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Probable AD according to NINCDS-ADRDA criteria
    2. Florbetaben-PET scan at screening consistent with the presence of amyloid pathology
    3. Mini-Mental Status Examination (MMSE) 18 – 28 points*
    4. Age over 40 and less than 90 years**
    5. Patients receiving a stable dose of an acetylcholinesterase inhibitor for at least 4 months prior to baseline
    6. Patients cared for by a reliable spouse or caregiver to assure compliance, assist with clinical assessments and report safety issues
    7. Women must be post-menopausal for at least one year, surgically sterilized or using reliable contraceptive measures
    8. Patient who in the opinion of the investigator are able to understand and provide written informed consent
    9. Patients and caregivers must be fluent in one of the languages of the study and able to comply with all study procedures
    10. The patient is lucid and clear and oriented x4 and is able to provide their written informed
    consent (applicable in Sweden only).
    * For cohort 3 booster injection, the previous lower limit of 18 points for the MMSE will not be required but in all
    cases patients must be oriented in time, place, person and current activities and able to give informed consent
    in the opinion of the investigator in order to take part.
    ** For cohort 3 booster injection, no upper age limit applies.
    E.4Principal exclusion criteria
    1. Patients whose MRI scan within the last 6 months shows alternative pathology including severe vascular encephalopathy and/or more than 5 micro-hemorrhages.
    2. Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease
    3. Patients with any unstable medical condition (e.g. epilepsy, uncontrolled hypertension) which would hamper safety assessments
    4. Patients receiving memantine within 3 months prior to baseline (for cohort 3 booster injection, memantine is allowed)
    5. Patients receiving any anticoagulant drug
    6. Patients with a history of hemorrhagic stroke
    7. Patients with a history of non-hemorrhagic stroke or myocardial infarction within the last year
    8. Patients with a history of major psychiatric disorder within the past 2 years
    9. Patients with a history of inflammatory neurology disorders including meningoencephalitis
    10.Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
    11. Patients with a history of autoimmune disease
    12. Patients with a history of cancer other than skin cancer within the past 5 years
    13. Patients who have received any vaccine within the past 2 months before baseline
    14. Patients who have previously received AD immune therapeutic agents or vaccines
    15. Patients anticipated to receive any vaccination other than influenza vaccine during the study
    16. Patients unable to undergo MRI examination for any reason, including metal implants contraindicated for MRI studies and claustrophobia
    17. Patients with a positive HIV test at screening
    18. Patients with positive syphilis serology
    19. Women who are pregnant or planning to be pregnant, or who are lactating
    E.5 End points
    E.5.1Primary end point(s)
    - Safety and tolerability assessments: Adverse events; global assessment of tolerability; physical-, neurological- and psychiatric examination; vital signs; MRI imaging; electrocardiogram; routine hematology and biochemistry evaluation in blood- and urine; inflammatory markers in blood and cerebrospinal fluid
    - Biological assessments: Immune response titer (serum anti-Aβ1-42 IgG titer)
    - Efficacy assessments: Change from baseline over 1 year of total Cognitive score (Neuropsychological Test Battery) (for Step 2 only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety and Tolerability: all time points
    - Biological assessments: at multiple visits
    - Efficacy assessments: NTB change from baseline at different visits
    E.5.2Secondary end point(s)
    - Biological assessments: Brain Aβ assessed by PET amyloid imaging, whole brain and hippocampal volume assessed by MRI (for Step 2 only), T-cell activation assessed by ELISPOT analysis, Inflammatory cytokines titer in blood, Biomarkers in blood and CSF (e.g. total tau and phosphotau and Aβ levels (Aβ1-42 and Aβ1-40)), Immune response in blood/CSF (e.g. anti-Aβ1-42 IgM titer in blood and anti-Aβ1-42 IgG titer in blood/CSF), TLR4 expression, TLRs and NLRs expression
    - Efficacy assessments: Global function [change from baseline in CDR (Clinical Dementia Rating Scale) sum of boxes], Activities of Daily Living (ADL) [change from baseline in Disability Assessment in Dementia (DAD)], other cognitive tests [change from baseline in ADAS-cog, MMSE, total NTB (including individual components, for Step 1 only)]; Behavior (change from baseline in NPI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Biological assessments: at multiple visits
    - Efficacy assessments: at multiple visits
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Adaptive design study with Phase I & II included
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The subjects will be treated for approximately 12 months (treatment period) and will enter a follow-up of 24 months (follow-up period). The end of the trial corresponds to the Last Patient Last Visit which is considered to be the last visit of the follow-up period.



    The item E.8.9 below is valid for each subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    F.4.2.2In the whole clinical trial 198
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No treatment is planned to be provided to any subjects after the trial. Any decision on this will be taken once all study data is analyzed.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-16
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